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HanAll Biopharma Reports Q1 2024 Financial Results and Provides Business Update

ROCKVILLE, Md. and SEOUL, South Korea, April 30, 2024 /PRNewswire/ — HanAll Biopharma Co., Ltd. (KRX: 009420.KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, reported financial results for first quarter 2024 and provided business updates.

HanAll Biopharma achieved 18.4 percent revenue growth in the first quarter compared to the same period last year, recording a revenue of 34.1 billion Korean Won (KRW), driven by continued strong sales across key products. The operation income recorded 0.1 billion KRW.

Advancements in R&D programs continued, with HL161ANS (IMVT-1402), a second-generation antibody targeting IgG-mediated autoimmune diseases, securing a joint patent in the U.S. from the United States Patent and Trademark Office (USPTO). Additionally, initial data readouts from batoclimab Phase 2b study in Chronic inflammatory demyelinating polyneuropathy (CIDP) are anticipated in mid-2024.

Preparation for the Phase 3 VELOS-4 study in dry eye disease continued throughout the first quarter, with plans to initiate the VELOS-4 study in the second quarter.

The HL192 (ATH-399A) Phase 1 study for Parkinson’s Disease (PD) progressed in the first quarter 2024 and top-line results are expected in the second half of 2024.

“We are pleased to end the first quarter with solid performance, driven by our anti-FcRn assets and our momentum of innovations.” said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma. “As we continue to advance our clinical programs and explore new opportunities, we remain confident that we are well-positioned for continued growth and success in the global market,” he added.

First Quarter 2024 BUSINESS UPDATE
Pipeline Development Highlights

A comprehensive update of HanAll’s public pipeline development below includes an overview of research along with lists of compounds, targeted indications, and developmental phases.

AUTOIMMUNE DISEASES PROGRAMS
Batoclimab (HL161BKN)

A novel, fully human, subcutaneously administered antibody targeting FcRn with the potential to address multiple IgG-mediated autoimmune diseases. Batoclimab is designed to selectively bind to FcRn, which plays a role in recycling IgG, thereby reducing levels of harmful IgG antibodies.

HL161ANS

Another novel, fully human, subcutaneous antibody molecule that inhibits FcRn-mediated recycling of IgG is designed to deliver maximum lgG reductions while minimizing interference with albumin recycling.

OPHTHALMIC DISEASE PROGRAM
Tanfanercept (HL036)

A novel topical protein therapy for ophthalmic diseases, including dry eye disease (DED), which inhibits TNF, a key mediator of ocular inflammation.

NEUROLOGY PROGRAM
HL192 (ATH-399A)

A pipeline candidate from NurrOn Pharmaceuticals (originating from Harvard Medical School’s Molecular Neurobiology Laboratory) that targets Nurr1, a master regulator in dopaminergic neuron development and maintenance, is being developed to treat neurodegenerative diseases, including Parkinson’s disease (PD).

ONCOLOGY PROGRAMS
HL187/ HL186

HL187 is a monoclonal antibody that targets TIGIT (T cell immunoreceptors with Ig and ITIM domains Immunoreceptor tyrosine-based inhibitory motif domains). HL186 is a monoclonal antibody that targets TIM-3 (T cell Ig and mucin domain-3). These antibodies are being developed in collaboration with Daewoong Pharmaceutical as potential oncology treatments.

FINANCIAL HIGHLIGHTS (CONSOLIDATED)
Key Highlights 

(KRW in billion) 

Q1 2024

Q1 2023

% change 

Sales 

34.1

28.8

+18.4 %

Gross Profit 

18.6

15.7

+18.4 %

Selling, marketing and administrative expenses 

13.2

11.5

+14.5 %

Research and development expenses 

5.3

5.9

-10.8 %

Operating income

0.1

(1.7)

N/A

Net Income

(0.3)

(1.3)

N/A

 

About HanAll Biopharma

HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company with a presence in Korea, the USA, Japan, and Indonesia with a mission of making meaningful contributions to patients’ lives by introducing innovative, impactful medicines to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in the therapeutic areas of endocrine, circulatory, and urologic diseases for over 50 years.

HanAll has also expanded its focus to immunology, oncology, neurology, and ophthalmology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. Its lead pipeline asset, HL161 (INN: batoclimab), an anti-FcRn antibody, is being developed in Phase 3 and Phase 2 trials across the world for the treatment of autoimmune diseases including generalized myasthenia gravis (gMG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves’ disease (GD). Another main asset, HL036 (INN: tanfanercept), a TNF inhibitor protein, is being evaluated in Phase 3 clinical studies in the US and is also being evaluated in China for the treatment of dry eye disease. HL161ANS, an anti-FcRn antibody targeting multiple indications, and HL192 (ATH-399A), a Nurr1 activator currently targeting Parkinson’s Disease, are also being evaluated in Phase 1 clinical studies (healthy volunteers). For further information, visit our website and connect with us on LinkedIn. For any media inquiries, please contact HanAll PR/IR (pr@hanall.com, ir@hanall.com).

Disclaimer Statement 

The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should,” and include statements HANALL (the company, we) makes concerning its 2024 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and the company, and its collaboration partners’, advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company’s actual results may differ materially from those predicted by the forward-looking statements. These may include various significant factors, such as our expectations regarding the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities, and regulatory approval requirements. In addition, performance may be affected by our reliance on collaborations with third parties, estimating the commercial potential of our product candidates, our ability to obtain and maintain protection of intellectual property of technologies and drugs, our limited operating history, and our ability to obtain additional funding for operations and to complete the development and commercialization of product candidates. A further list and description of these risks, uncertainties, and other risks can be found in Korea Stock Exchange (KRX) filings and reports, including in our most recent annual report as well as subsequent filings and reports filed by the company with the KRX. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. We undertake no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by Korean law and regulations. 

 

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